BEUDAMED
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    DIVA ZSP2105CMI with QUBYX PerfectLum bundle

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577832·CoRoent Ant TLIF PEEK, 16x10x32mm 8°

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017804·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Femoral Entry Drill

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215046262·

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 4, 2023

    PLANMECA PROMAX 3D

    FDA 510(k)
    FDA Class 2 ·Dental

    CLEARFIL MAJETY POSTERIOR

    FDA 510(k)
    FDA Class 2 ·Dental

    RESIDUAL LIMB LENGTHENING SYSTEM

    FDA Adverse Event
    Injury ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code HSB·August 1, 2016

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 10, 2013

    DORNIER HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·DORNIER MEDTECH AMERICA, INC.·Product code GEX·May 16, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017

    MISAGO RX Self Expanding Peripheral Stem

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 7, 2016

    LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016